The purpose of this clinical study is to evaluate the immunogenicity, the safety and the tolerability of rMenB+OMV NZ and MenACWY vaccines when concomitantly administered to healthy subjects 16-18 years of age.
Criteria:Ø Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits) or/and subjects’ parent(s)/Legally Acceptable Representative(s) [LAR(s)] who, in the opinion of the investigator, can and will comply, with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits).
Ø Previous vaccination with one dose of quadrivalent meningococcal conjugate vaccine (MenACWY, Menveo or Menactra) at least 4 years prior to informed consent and assent as applicable (according to the subject’s age). • Written or /witnessed/thumb printed informed consent obtained from the subject/parent(s)/LAR(s) of the subject prior to performance of any study specific procedure.
Ø Written informed assent obtained from the subject (if applicable) along with informed consent from the subject's parent(s)/LAR(s) prior to performing any study specific procedure.
Ø A male or female between, and including, 16 and 18 years of age at the time of the first vaccination.
Ø Healthy subjects as established by medical history and clinical examination before entering the study.
Ø Female subjects of non-childbearing potential may be enrolled in the study. Nonchildbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause (please refer to Section 12.6.1 for definitions of menarche and menopause).
Ø Female subjects of childbearing potential may be enrolled in the study, if the subject (refer to Section 12.6.1 for definitions of woman of childbearing potential and adequate contraception): − has practiced adequate contraception for 30 days prior to vaccination, and − has a negative pregnancy test on the day of vaccination, and − has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series. Prior to receipt of second and third study vaccination, subjects must be evaluated to confirm that they are eligible for subsequent vaccination. If subjects do not meet any of the original inclusion criteria listed above, they should not receive additional vaccinations.